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FDA 510(k) Application Details - DEN180059
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN180059
Device Name
Nerivio Migra
Applicant
Theranica Bioelectronics ltd
45 Hamelakha st. Poleg Industrial Park
Netanya 4250574 IL
Other 510(k) Applications for this Company
Contact
Alon Ironi Ironi
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QGT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/2018
Decision Date
05/20/2019
Decision
DENG -
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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